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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
UBS
Express Scripts
Citi
Cerilliant
Moodys
Queensland Health
QuintilesIMS
Covington

Generated: December 12, 2017

DrugPatentWatch Database Preview

KYPROLIS Drug Profile

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Which patents cover Kyprolis, and what generic alternatives are available?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-seven patent family members in thirty-five countries and eight supplementary protection certificates in seven countries.

The generic ingredient in KYPROLIS is carfilzomib. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

Summary for KYPROLIS

Drug patent expirations by year for KYPROLIS

Pharmacology for KYPROLIS

Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-001Jul 20, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-001Jul 20, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-001Jul 20, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-002Jun 3, 2016RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-001Jul 20, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-001Jul 20, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-002Jun 3, 2016RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-002Jun 3, 2016RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-002Jun 3, 2016RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Onyx TherapKYPROLIScarfilzomibPOWDER;INTRAVENOUS202714-001Jul 20, 2012RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Paragraph IV (Patent) Challenges for KYPROLIS

Drugname Dosage Strength RLD Submissiondate
carfilzomibFor Injection30 mg/vialKyprolis 20271410/5/2017
carfilzomibFor Injection60 mg/vialKyprolis7/20/2016

Non-Orange Book Patents for Tradename: KYPROLIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,198,270Compounds for proteasome enzyme inhibition► Subscribe
8,088,741Compounds for enzyme inhibition► Subscribe
8,324,174Compounds for enzyme inhibition► Subscribe
8,207,124Compounds for enzyme inhibition► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: KYPROLIS

Country Document Number Estimated Expiration
Japan2007538081► Subscribe
Hong Kong1107948► Subscribe
Hong Kong1152716► Subscribe
Japan2014141456► Subscribe
EcuadorSP11011027► Subscribe
Israel223546► Subscribe
Spain2617560► Subscribe
World Intellectual Property Organization (WIPO)2005111008► Subscribe
Japan2008522981► Subscribe
Spain2360811► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: KYPROLIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0160008 00189Estonia► SubscribePRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
015Luxembourg► SubscribePRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123
2016 00014Denmark► SubscribePRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
2016010Lithuania► SubscribePRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
0805Netherlands► SubscribePRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123
2016010,C1781688Lithuania► SubscribePRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
90013-6Sweden► SubscribePRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/15/1060 20151123
C0017France► SubscribePRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
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Serving leading biopharmaceutical companies globally:

Colorcon
Accenture
US Army
Johnson and Johnson
Novartis
Argus Health
Baxter
Merck
Fuji
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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